NCT01518790

Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children

Evaluation of Short Course, Single-dose Polyethylene Glycol (PEG) 3350 Regimen for Colonoscopy Bowel Preparation in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Walter Reed National Military Medical Center · Federal
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators propose to conduct a prospective study of a widely used bowel preparation regimen (polyethylene glycol 3350 + a sports drink) on pediatric patients who undergo a colonoscopy performed by the pediatric gastroenterology service at WRAMC/WRNMMC between 1 Sep 2010 and 31 Dec 2011. This study will involve the following: determine efficacy of the cleanout, assess tolerability and acceptance of the regimen, determine an appropriate duration to complete the regimen and assess for any electrolyte changes or side effects.

Detailed description

Purpose: It is hoped that by determining acceptability, safety and efficacy of this widely used short course, single-dose bowel preparation regimen, pediatric gastroenterologist can have a standardized bowel preparation for colonoscopy that will be acceptable to pediatric patients and their parents. Research Design: This study is a prospective medication trial. It will utilize laboratory data to detect any electrolyte changes, a patient questionnaire to assess an acceptable duration, tolerance and side effects of the regimen. Efficacy of the cleanout will be assessed using a published standardized bowel preparation scale by the endoscopist at the completion of the colonoscopy. Methodology /Technical Approach (including the number of subjects to be studied.): We estimate that 50 patients aged 8-18 years old military dependents who are undergoing a colonoscopy by the Pediatric Gastroenterology service at WRAMC/WRNMMC will be enrolled in the study between 1 Sep 2010 and 31 Dec 2011.

Conditions

• Colonoscopy

Interventions

Type	Name	Description
DRUG	polyethylene glycol 3350	PEG 3350 (238 grams) mixed with 1.9 L (64 oz) of Gatorade, given in 8 oz increments every 15-30 minutes until complete starting at 18:00 on day prior to colonoscopy (max time to completion 6 hours).

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2012-01-26
• Last updated: 2016-02-10

Locations

1 site across 1 country: United States